Kornimate/medical-research-clean huggingface dataset:
technology that permits focal dose of antibiotics to be delivered to lower limb(s) of diabetic patients

Conditions: Diabetes; Infection

Summary: the use of the percutaneous isolated limb procedure (pilp) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that iv antibiotics are needed in order to salvage the limb or life.

during the pilp procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.

Eligibility criteria:
inclusion criteria: * m or f subjects 18 - 90 years old * subject has pre-existing diabetes diagnosis * subject has significant infection below the ankle of soft tissue and may include bone, and iv antibiotics are needed in order to salve limb or life * consequence of infected wound would require std of care share debridement * subject willing and able to provide written informed consent * subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations * procedural inclusion criteria: successful cannulation of the femoral artery and vein and placement of the venous support device exclusion criteria: * allergy to contrast media * known bleeding disorder including thrombocytopenia * recent ami or elevated troponin levels within last 30 days * penicillin sensitivity; timentin sensitivity * female subjects known to be or suspected to be pregnant or lactating * subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure * subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment * the pi determines the subject is not an appropriate subject for the study * procedural exclusion criteria: subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device * known severe proximal femoral artery vascular disease precluding placement of perfusion catheters

Keywords: diabetes lower limb infection significant wound infections intravenous antibiotics timentin
annual study to investigate inactivated subunit influenza vaccine due to new virus strains for the 09/10 season

Conditions: Influenza

Summary: influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. in europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. the current study is a phase iiia clinical trial with a commercially available vaccine (influvac®) supplied in pre filled syringes. it is part of the ongoing clinical trial program for influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged \>= 18 and \ = 61 years of age (elderly).


Eligibility criteria:
inclusion criteria * willing and able to give informed consent and able to adhere to all protocol required study procedures. * men and women aged \>= 18 and \ = 61 years of age at the day of study vaccination. * being in good health as judged by medical history, physical examination and clinical judgment of the investigator. exclusion criteria * known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. * a serious adverse reaction after a previous (influenza) vaccination. * presence of any significant condition that may prohibit inclusion as determined by the investigator. * having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period. * a history of guillain-barré syndrome or active neurological disease.

Keywords: influenza vaccine chmp criteria
pelvic floor dysfunction among female physiotherapy students: a cross-sectional study

Conditions: Pelvic Floor Disorders

Summary: this study aims to: 1. estimate the prevalence of pelvic floor dysfunction among female physiotherapy students at cairo university. 2. identify potential risk factors that may be associated with pelvic floor dysfunction in this student population. 3. assess the level of awareness regarding pelvic floor health among female physiotherapy students at cairo university. 4. explore how female physiotherapy students at cairo university utilize available healthcare resources for managing pelvic floor-related concerns.

pelvic floor dysfunction (pfd) is a global health problem that affects millions of women worldwide. it encompasses a broad range of interrelated disorders affecting the pelvic region, including urinary incontinence, pelvic pain, constipation, sexual dysfunction, and pelvic organ prolapse. while pfd is often associated with pregnancy, childbirth, and aging, recent studies suggest that these conditions may also affect younger populations, including nulliparous women. pelvic floor health is crucial for supporting pelvic organs, maintaining continence, and facilitating sexual function. however, the impact of pfd on women's health and quality of life is significant, with important consequences for physical and mental well-being. these disorders often coexist and compound each other's impact, leading to disabling symptoms, embarrassment, social isolation, impaired task performance, loss of personal and intimate relationships, and reduced participation in leisure activities. despite the substantial burden of pfd, there is a lack of comprehensive data on the prevalence, risk factors, and awareness levels of these conditions among specific populations, particularly young women pursuing higher education. physiotherapy students, who are expected to have a good understanding of musculoskeletal and pelvic health, represent an important group to study in this context.

Eligibility criteria:
inclusion criteria: * virgin undergraduate physiotherapy students. * their age will range from 18-25 years. exclusion criteria: * neurological disorders or injuries that may affect pelvic floor function (e.g., fibromyalgia and multiple sclerosis). * mental health or cognitive disorders that could affect data collection. * females who have undergone any form of abdominal surgery prior to the time of the study. * females with current use of medications that may affect pelvic floor function (e.g., anticholinergics, opioids, antidepressants).
conservative versus surgical management of idiopathic normal pressure hydrocephalus (inph)

Conditions: Normal Pressure Hydrocephalus

Summary: this study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.

by comparing one group with active csf shunting with another with non .

Eligibility criteria:
inclusion criteria: * idiopathic normal pressure hydrocephalus exclusion criteria: * alzheimer disease * vascular dementia

Keywords: nph hydrocephalus shunt
brexpiprazole for the long-term treatment of patients with agitation associated with dementia of the alzheimer's type

Conditions: Agitation Associated With Dementia of the Alzheimer's Type

Summary: to evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.


Eligibility criteria:
inclusion criteria: * patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at week 10 of the double-blind trial. * patients whose caregiver can properly collect the necessary information. exclusion criteria: * patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial. * patients who had delirium during the double-blind trial.
the effect of sleep hygiene and exercise therapy in children with sleep bruxism

Conditions: Sleep Bruxism, Childhood

Summary: the aims of this study were to determine the relationship between sleep bruxism, oral habits, and sleep habits and establish treatment approaches in children.

this cross-sectional study was conducted on children aged between 6-and 13 years, diagnosed with sleep bruxism (sb). initially, 82 children with a diagnosis of sb were evaluated. among those, 37 children volunteered were followed for 8 weeks to investigate the effects of the education, sleep hygiene and therapeutic exercise program. sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise. therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. they were asked to repeat each exercise 5 times and 5 times a day for 8 weeks.

Eligibility criteria:
inclusion criteria: * children between the ages of 6 - 13, * having a diagnosis of sleep bruxism,, * and a parent signing informed consent for participation in the study. exclusion criteria: * children who received orthodontic treatment, * children with the dentofacial anomaly, a history of tmj surgery, having a medical history of neurological or psychiatric disease * and those who could not cooperate were excluded from the study.

Keywords: bruxism sleep habits oral habits children
cognitive training for digital biomarkers

Conditions: Cognitive Decline; Healthy Aging

Summary: this study aims to conduct cognitive training for digital biomarkers among older adults.

the prevalence of dementia in rural areas is higher than in urban areas. however, the resource and research input on cognitive training for rural older adults still needs improvement. there is also no solution for preventing or early detection of dementia in rural areas. unlike biomarkers that require invasive detection, digital biomarkers have been advocated in recent years for early disease prediction. however, there are still few studies on the effectiveness of digital biomarkers in evaluating cognitive function in the elderly. in addition, although previous studies have confirmed that cognitive training can be effective for older adults, it is difficult for the elderly in rural areas to obtain these cognitive-promoting resources due to distance. moreover, the autonomy and right of choice of older adults are the keys to the success of their health behavior change.

Eligibility criteria:
inclusion criteria: 1. at least 60 years of age, can communicate in chinese (taiwanese) 2. bring your own mobile device with internet access. 3. can act alone without physical impairment；full score of basic activities of daily living scale and instrumental activities of daily living scale. exclusion criteria: 1. dementia diagnosed by a physician and in compliance with icd-10 2. physician diagnosed with significant mental illness or communication impairment 3. participated in other cognitive training studies within the past year 4. medical conditions associated with rapid functional and cognitive decline 5. severe visual impairment

Keywords: digital biomarker
optima coronary artery disease (cad) (optimal mechanical evaluation)

Conditions: Heart Failure; Ischemic Cardiomyopathy

Summary: to evaluate the impact of left ventricular (lv) lead location on lv mechanical function.


Eligibility criteria:
inclusion criteria 1. ischemic cardiomyopathy 2. left ventricular ejection fraction less than 40% 3. clinical indication for invasive electrophysiology testing 4. patient is at least 18 years of age exclusion criteria 1. unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months 2. cva or tia within the past 6 months 3. prosthetic heart valve 4. patient is status post heart transplant 5. women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to eps procedures being performed.

Keywords: ischemic cardiomyopathy cardiac resynchronization therapy lv structure and function
different surgical techniques used for prolapse repair in elderly patient

Conditions: Unrecognized Condition

Summary: the investigator aimed to compare various pelvic floor repairs in female aged from 70 to 80 years old, to see which procedure in terms of treatment-related complications of scp, vmr and ntr by comparing the operative and functional outcomes in this patient population.

pelvic organ prolapse (pop) is a global health care issue that could have a significant impact on pelvic floor function and quality of life (qol), while seldom having the potential to be life-threatening. prevalence of pop increases with age. in women older than 80, 11% undergo a surgical procedure. the incidence of degenerative diseases and multiple co-morbidities increases with age, and advanced age is also associated with an increase in morbidity generally for gynecologic procedures. furthermore, greater comorbidity beforehand can predispose patients to postoperative complications such as bleeding, hematoma, pain, infectious. as a result hospital stays are longer and the surgical results are compromised. surgical techniques should optimize functional results and minimize complications. in pop surgery, younger women are good candidates for sacrocolpopexy (scp), because of the improved long term functional result, while women older than 80 may have a satisfactory outcome with fewer complication with a vaginal repair with mesh (vmr) or native tissue (ntr). the increasing prevalence of pop, and the increasing population of women aged 70-80 requires an evaluation of the appropriate surgical management since women in this age group may be candidates for all types of surgical repair.

Eligibility criteria:
inclusion criteria: * patients with a pelvic organ prolapse * patients aged between 70 and 80 years old * patients with symptomatic anterior, apical and/or posterior compartment prolapse, stage 2 or greater exclusion criteria: * patients with a previous history of pelvic surgery for a cancer diagnosis are excluded * patients with a surgical repair specific to the existing defect site (for group 2)

Keywords: elderly native tissue repair pelvic organ prolapse sacrocolpopexy vaginal mesh repair
developing the unified protocol-single session experience platform for adolescent mental health

Conditions: Depression; Depression, Anxiety; Depression in Adolescence; Anxiety

Summary: this sbir phase i proposal will develop and test the acceptability and feasibility of a new suite of digital single-session interventions, specifically applying unified protocol core principles for emotional disorders, to produce a highly accessible, engaging, and scalable product to help address the clinical needs of youth.

this project proposes develop a suite of single session intervention (ssi) modules using the unified protocol (up) core principles. for phase i, the team will develop two ssi modules from up: awareness of physical sensations and emotional experiences, and being flexible in your problem solving. for the acceptability test (specific aim 2), investigators will recruit 60 youth who are screened as eligible based on the internalizing subscale of the pediatric symptom checklist. caregivers/parents of youth will be recruited using targeted social media advertisements, where they can view a brief study description and complete the eligibility screener. if interested, caregivers can provide contact information for the study team to conduct consent and assent processes. following consent and enrollment, participants will receive private login information to access the prototype and study materials. first, participants will complete pre-surveys that collect demographic information and responses to the revised children's anxiety and depression scale (rcads). next, participants will take a brief survey to assess knowledge of intervention concepts presented in the first module: mindful awareness. then, they will engage with the module and provide feedback on the quality of its components. then, they will complete the knowledge assessment again. participants will complete the same process for the second module: flexible problem solving (pre knowledge check, review, rate the quality, and post knowledge check). participants will complete a product evaluation to rate their overall experience with the prototype (quality, usability, innovation, feasibility, and value) and the degree they advocate for full product development. finally, participants will take the rcads at the end of the review period. there will also be an opportunity for participants to participate in a brief feedback call to provide additional feedback.

Eligibility criteria:
inclusion criteria: * be ages 13 to 17 years old * be willing and available to take part in the study requirements * be fluent in english * have access to the internet with a mobile device or personal computer * have parent permission * screen as eligible according to the internalizing subscale from the pediatric symptom checklist exclusion criteria:
frailty in the perioperative period

Conditions: Frailty

Summary: the presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. in this prospective observational study, an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery. 100 patients are being included for 3 months. the main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery in our hospital and its association with postoperative mortality.

the presence of frailty is associated with a high risk of complications in the perioperative period, increasing morbidity and mortality, hospital stay, and loss of quality of life. this is a prospective observational study in which an evaluation of frailty was performed in patients older than 65 years old who undergo scheduled and urgent surgery, including 100 patients for 3 months. the main objective is to evaluate the prevalence of frailty in patients older than 65 years undergoing surgery and its association with postoperative mortality. the secondary objectives were the following: to assess the association between frailty and increased days of hospital stay, hospital readmission, and unexpected admission to icu areas; to assess whether patients with greater frailty suffer a greater loss of postoperative functional independence; to evaluate type and frequency of complications; and to evaluate which scale is most useful to implement in the perioperative setting (edmonton frailty test, barthel index, mini-mental test, charlson index).

Eligibility criteria:
inclusion criteria: * patients over 65 years old undergoing urgent or scheduled surgery for three months. exclusion criteria: * language barrier * cognitive impairment or inability to assist in clinical assessment during the study * refusal to participate in the study

Keywords: preoperative frailty postoperative complications
phase ii clinical study of the safety and efficacy of the relay thoracic stent-graft

Conditions: Thoracic Aortic Aneurysm; Penetrating Ulcers

Summary: this study is a continuation of the pivotal trial studying the safety and efficacy of the relay thoracic stent-graft system to treat thoracic aortic aneurysms. efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the relay thoracic stent-graft) through 1 year. safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the relay thoracic stent-graft to those who underwent surgical repair.


Eligibility criteria:
inclusion criteria: * subjects with diagnosed descending thoracic aneurysm or penetrating ulcer * subjects whose anatomy can accommodate the relay device * subjects who consent to participate * subjects who agree to a follow-up schedule exclusion criteria: * subjects with lesions other than thoracic aneurysm and penetrating ulcer * subjects with less than 1 year life expectancy * subjects who are pregnant * subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., marfan's syndrome, morbid obesity, severe coronary artery disease) * subjects participating in another investigational study

Keywords: relay thoracic aneurysm
safety and efficacy of the lma supreme when inserted with patients in the prone position

Conditions: Airway Obstruction

Summary: this study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the lma supreme laryngeal mask airway when used according to the device's instructions for use.

this study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the lma supreme laryngeal mask airway when used according to the device's instructions for use. during surgery, standard treatment will be applied, complemented with the recording of study parameters related to safety, efficacy and performance of the lma supreme laryngeal mask airway.

Eligibility criteria:
inclusion criteria: * 18 to 70 years of age * american society of anesthesiology classification (asa) i-iii patients * fasting for 8 hours * scheduled surgery with indication for laryngeal mask airway exclusion criteria: * have contraindicating conditions * have had radiotherapy to the neck involving the hypopharynx (risk of trauma, failure to seal effectively). * have inadequate mouth opening to permit insertion * history of hiatal hernia * scheduled for minimally invasive spine stabilization procedures such as transforaminal lumbar interbody fusion (tlif), anterior cervical discectomy and fusion (acdf) (all have neuromonitoring/general endotracheal intubation) * scheduled for joimax procedure (initial anesthetic is mac) * unable to safely position themselves prone with assistance * history of previous failed lma supreme placement * bmi greater than or equal to 53 * outside age or asa range specified in inclusion criteria * inability to comply with study requirements including follow-up
evaluation of the school kids influenza prevention project

Conditions: Childhood Influenza Vaccination; School-located Influenza Vaccination

Summary: children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.


Eligibility criteria:
inclusion criteria: - enrolled in the urban school district exclusion criteria: - attends a school in the urban district containing a school-based health center

Keywords: influenza vaccination rates respiratory tract diseases